The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with ...

Dr. Debu Tripathy discusses the FDA approval of Enhertu in unresectable or metastatic hormone receptor HR+, HER2-low or -ultralow breast cancer.

Roche has secured a new FDA approval for its first companion diagnostic test aimed at identifying breast cancer patients with ...

Datroway is the second ADC developed by the pharmaceutical companies Daiichi Sankyo and AstraZeneca to get FDA approval.

Roche is the recipient of the new approval, getting the go-ahead from the US regulator for its PATHWAY HER2 (4B5) test to ...

The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which ...

January's FDA oncology approvals offer new treatment options for breast cancer, mantle cell lymphoma, and other malignancies.

Roche’s PATHWAY HER2 (4B5) test helps identify patients with HER2-ultralow breast cancer, who may be eligible for targeted ...

The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its ...

ENHERTU is a specifically engineered HER2-directed antibody ... results were consistent between patients with HER2-low and HER2-ultralow expression. 2 The FDA approval of the new HER2-ultralow ...

Shares of solid tumor concern Zymeworks Inc. have barely budged since the company obtained its first approval. Click here to read why ZYME stock is a Hold.

AstraZeneca scrapped plans for a £450 million UK vaccine plant after rejecting a £78 million government offer, citing ...